MARCAINE- bupivacaine hydrochloride injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Bupivacaine Hydrochloride (UNII: 7TQO7W3VT8) (Bupivacaine - UNII:Y8335394RO)

Commercializzato da:

General Injectables & Vaccines, Inc

Via di somministrazione:

EPIDURAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

MARCAINE is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS.) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of MARCAINE in these patients. MARCAINE is not recommended for intravenous regional anesthesia (Bier Block). See WARNINGS. The routes of administration and indicated MARCAINE concentrations are: MARCAINE is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. MARCAINE is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of MARCAINE solutions.

Dettagli prodotto:

These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] MARCAINE #Solutions of MARCAINE that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

MARCAINE - BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
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MARCAINE (BUPIVACAINE HCL) 0.5% INJECTION, USP 30 ML SINGLE DOSE VIAL
DES CRIPTION
Rx Only
Bupivacaine hydrochloride is 2-Piperidinecarboxamide,
1-butyl-N-(2,6-dimethylphenyl)-,
monohydrochloride, monohydrate, a white crystalline powder that is
freely soluble in 95 percent
ethanol, soluble in water, and slightly soluble in chloroform or
acetone. It has the following structural
formula:
Epinephrine is (-)-3,4-Dihydroxy-a-[(methylamino)methyl] benzyl
alcohol. It has the following
structural formula:
MARCAINE is available in sterile isotonic solutions with and without
epinephrine (as bitartrate)
1:200,000 for injection via local infiltration, peripheral nerve
block, and caudal and lumbar epidural
blocks. Solutions of MARCAINE may be autoclaved if they do not contain
epinephrine. Solutions are
clear and colorless. Bupivacaine is related chemically and
pharmacologically to the aminoacyl local
anesthetics. It is a homologue of mepivacaine and is chemically
related to lidocaine. All three of these
anesthetics contain an amide linkage between the aromatic nucleus and
the amino, or piperidine group.
They differ in this respect from the procaine-type local anesthetics,
which have an ester linkage.
MARCAINE — Sterile isotonic solutions containing sodium chloride. In
multiple-dose vials, each mL
also contains 1 mg methylparaben as antiseptic preservative. The pH of
these solutions is adjusted to
between 4 and 6.5 with sodium hydroxide or
hydrochloric acid.
MARCAINE with epinephrine 1:200,000 (as bitartrate)—Sterile isotonic
solutions containing sodium
chloride. Each mL contains bupivacaine hydrochloride and 0.0091 mg
epinephrine bitartrate, with 0.5
mg sodium metabisulfite, 0.001 mL monothioglycerol, and 2 mg ascorbic
acid as antioxidants, 0.0017
mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as
stabilizer.
In multiple-dose vials, each mL also contains 1 mg methylparaben as
antiseptic preservative. T